Cartridge and centrifuge having a cartridge

ABSTRACT

The invention relates to a cartridge ( 1 ) for accommodating blood bags ( 35 ), which is provided for the separation of blood components for the application in a centrifuge. The cartridge ( 1 ) has a partition wall ( 3 ) which separates a blood bag section ( 5 ) positioned radially inside from a product section ( 7 ) positioned radially outside, and a cover ( 9 ) disposed in a mounting position above the blood bag section ( 5 ). The cover ( 9 ) is connected to the partition wall ( 3 ) pivotally in a first point ( 11 ) and detachably in a second point ( 13 ), so that the blood bag section ( 5 ) is freely accessible by means of laterally pivoting the cover ( 9 ) out of the way. The cartridge is applicable in the rotor of a centrifuge.

TECHNICAL FIELD

The invention relates to a cartridge which is in particular provided forthe application in a centrifuge in order to separate blood into itscomponents, and to a centrifuge having such a cartridge.

STATE OF THE ART

In transfusion medicine the so-called blood component therapy hasestablished itself since the beginning of the nineties. This means thatinstead of a whole blood conserve only those blood components areadministered to a patient that the individual patient requires. By meansof this separate administering of the individual blood components, it ispossible that one single blood conserve can provide optimal help to anaverage of 1.8 patients.

The essential blood components are

-   -   the red blood cells in the so-called erythrocyte concentrate        which are transfused in order to maintain the oxygen supply        after severe loss of blood.    -   the blood platelets in the thrombocyte concentrate which are        administered in cases of coagulation disturbances (haemophilia),        and    -   the blood plasma which is administered in cases of coagulation        disturbances and volume deficits. Apart therefrom, blood plasma        is an essential basic component for the production of many        medicaments.

The separation of the individual blood components which is defined ascell isolation is known to be effected by treating the blood in acentrifuge. By means of centrifuging the individual blood components areseparated and then each individual one can be filled into the respectivecontainers for further use.

Such centrifuge is for example known from document EP 1 351 772 B1.According to this state of the art, a plurality of cartridges arearranged around a hub in a rotor of a centrifuge. The cartridges arefirmly held in the rotor such that the blood bags are centrifuged in anupright position. Inside, the cartridges comprise accommodating devicesfor accommodating a blood bag containing whole blood and product bags inwhich the plasma and the erythrocyte concentrate are collected,respectively. In order to avoid a continued flowing and renewed mixingof the products after the individual components have been separated,various clamping means are provided in the cartridge for clamping theindividual tubes. Before removing the bags from the cartridge after theseparation has been effected, the individual connecting tubes of thebags must be sealed by appropriate measures. Only then can the clamps ofthe cartridge be opened, the bags be removed and the cartridge getprepared for accommodating a new set of bags.

After the separation and the drawing off of the plasma or the red bloodcells, a mixture called “buffy coat” remains in the blood bags. This“buffy coat” consists mainly of platelets as well as white and red bloodcells. For obtaining the platelets from this “buffy coat”, the latter isdiluted with an additive solution and this diluted “buffy coat” is thenagain separated into its components by centrifuging.

From document WO 03/089027 a system and a method for this purpose arealready known. This document discloses a centrifuge in which aring-shaped bag containing a mixture of “buffy coat” and additivesolution is inserted into its single chamber. The blood components arethen separated by means of a centrifuging operation and the separatedcomponents are transported via a tube line through a filter provided inthe area of the hub to a collection container also provided in the areaof the hub.

REPRESENTATION OF THE INVENTION Technical Object

It is the object of the invention to provide an improved cartridge and acentrifuge including the cartridge that allow a more economic cellisolation.

Technical Solution

The object of the invention is achieved by means of a cartridgeaccording to claim 1. Advantageous embodiments of the invention areachieved according to the dependent claims.

A cartridge according to the invention for accommodating blood bags,which is used for the application in a centrifuge in order to separatethe blood components, comprises a partition wall and a cover. Thepartition wall separates a blood bag section positioned radially insidefrom a product section positioned radially outside. The cover ispositioned above the blood bag section in a mounting position of thecartridge. The cover is connected to the partition wall pivotally at afirst point, and detachably at a second point. In this way, the bloodbag section is freely accessible by means of laterally pivoting thecover out of the way.

This enables a fast changing of the blood bag in the blood bag section.By means of the pivotal connection between the cover and the partitionwall one or several connecting tubes of the blood bag can be easilypositioned while the cover is being closed. Thus the tubes are optimallyfixed within a short period of time.

Advantageously, a recess for holding a tube of the blood bag and/or atube clamp can be formed in an upper section of the cover. Theserecesses enable the use of the original blood bags without furthermeasures for preparing the bag or the tube being required.

In the cover an operating device can be provided for operating a tubeclamp disposed on a tube of the blood bag. Since the clamps alreadydisposed on the tube can be opened and closed by means of the operatingdevice, it is not necessary to provide separate clamping means with thecartridge.

For an easy operation of the clamp, the operating device can protrudefrom the cover at a side surface located opposite the partition wallwhen the cover is closed.

In the recess a sensor can be provided, which can in particular be aphoto sensor. Depending on the color of the blood liquid transportedthrough the tube, this enables the execution of respective reactionssuch as operating the clamp in order to terminate the discharge of theblood liquid from the bag.

At a bottom surface of the cover an electric connection means can beprovided for the electric connection with a centrifuge. Thus it ispossible to transmit signals from a control device mounted inside thecentrifuge to the cartridge and in the reverse direction, respectively.

Furthermore, a fixture for a filter and/or for a product bag can beprovided in the product section of the cartridge. Accordingly, after thecover has been opened, the partly or completely emptied blood bag withthe remaining content can be removed from the cartridge together withthe filter and the product bag which for example contains the plasma orthe erythrocyte concentrate.

Advantageously, the fixture may comprise an outside wall which ispositioned radially outside the partition wall and which is providedwith a guiding means for guiding the tube. The guiding means can beprovided as a slot in the outside wall such that the tube can beinserted radially from the outside and from below into the fixture.

Advantageously, this enables that red blood cells that are transportedthrough the tube collect at the outside wall and at the bottom surfaceof the filter, and that there is no risk that the red blood cells aretransported further into the product bag.

At the top surface of the partition wall a recess for guiding the tubefrom the fixture radially inwards to second recesses in the top surfaceof the cover can be provided. Said second recesses are provided forholding the tube and a second tube clamp. In particular, these can beprovided in an essentially mirror-image manner relative to the firstrecesses.

At an upper edge, the partition wall can comprise a passage for feedingthe tube from the radially inside area of the partition wall to theradially outside area of the partition wall. Among other things, thisserves to position the tube and to ensure that the tube leads to thefilter radially from the outside and from below.

Advantageously, a second photo sensor can be provided in the secondrecesses and/or second operating device corresponding to the operatingdevice are provided in the cover for a tube clamp to be held in one ofthe second recesses. Particularly the second sensor enables theoptimization of the yield in cell isolation by means of outputting afinal signal for terminating the transportation combined with a signalfor closing the tube clamps, after an “attention” signal has been outputby the first sensor, starting out from a predetermined composition ofthe product in the tube.

The cartridge can furthermore be provided with a collecting tank whichis positioned radially outwards and which can embrace the productsection and parts of the blood bag section. Advantageously, a handlingdevice is provided inside the collecting tank to facilitate the handlingof the collecting tank and the cartridge partly embraced thereby. Thishandling device can be provided for example in the form of finger holesor handles.

The above described cartridge is provided for use in a centrifuge forthe separation of blood components. The centrifuge comprises a hub and arotor which revolves around the hub. Advantageously, in the rotoraccommodating boxes are provided around the hub, which are alsodescribed as system boxes and which are used for accommodating thecartridges. However, it is also possible to use a centrifuge in whichonly one cartridge is accommodated. Each cartridge can be removed freelyfrom the accommodating box and, thus, the centrifuge by operating alocking element connected to the accommodating box. These accommodatingboxes can be detachably connected to the rotor.

This enables a fast exchanging of the cartridges containing theseparated blood components with new cartridges containing bloodcomponents which are not yet separated while enabling a betterproduction yield in cell isolation and an optimized equipmentutilization.

In its non-operated state the locking element can assume a lockingposition. Thus an immediate locking is achieved as soon as a cartridgeis inserted into the accommodating box of the rotor. The locking elementcan furthermore be provided in the area of the hub or of theaccommodating box.

Furthermore the locking element can be provided at a support assigned tothe cartridge. Accordingly, the cartridge is then accommodated betweenthe support and one wall of the accommodating box and can only be movedupwards in one direction. This movement is, however, only possible by anoperation of the locking element. This makes a secure positioning of thecartridge in the accommodating box possible for the centrifugingoperation.

For holding the cartridge, the locking element in its non-operated statecan be engaged with a side surface of the cover, located opposite thepartition wall. A projection is formed on the locking element to preventan upward movement of the cartridge.

The support can furthermore comprise a contact pad for enabling anelectrically conductive connection between the accommodating box and thecartridge. The contact pad can consist of a plurality of electriccontact points.

At the support a pressing element can be provided so as to be radiallymovable into the section below the cover. This serves to press theseparated components from the blood bag into the tube, through whichthey are further transported to the filter and into the product bag.

A first section of a line from the blood bag can advantageously leadupwards and radially inwards. This eliminates an undesired escape ofliquids into the tube before the blood components are separated fromeach other.

The invention also relates to a method for cell isolation. The methodcomprises the following steps: inserting a blood bag containing wholeblood into a blood bag section of a cartridge, closing a cover of theblood bag section by pivoting the cover to the side, and positioning atube of the blood bag, connecting the tube to a filter in a productsection of the cartridge, inserting the cartridge into a rotor of acentrifuge by latching a locking element, spinning the centrifuge inorder to separate the blood components in the blood bag, applyingpressure onto the blood bag by means of a pressing element in order topress a blood component into the tube and further into the filter andinto a product bag positioned behind the filter, terminating thepressing and the spinning, operating the locking element and removal ofthe cartridge, opening the cover and removing the bags containing theseparated blood components.

On the one hand, the method according to the invention enables a fasterexchanging of the blood bags and product bags with new bags. On theother hand, the possibility to mount and remove the cartridges by oneturn of the hand enables an almost continuous performance of thecentrifuging and separation processes, since these only need to beinterrupted for the changing of the cartridges.

The cartridge and the centrifuge according to the invention are suitedfor the separation of cells and plasma from whole blood, on the onehand, but are also provided for extracting cells from the “buffy coat”that remains after a known centrifuging operation.

For this purpose, the “buffy coat” from several blood bags is collectedtogether with an additive solution in a new blood bag, and is mixed. Thenew blood bag corresponds to the blood bag according to the invention.Advantageously, the new blood bag can be provided with a tube and/or afilter, in particular one provided for the filtering of leukocytes.

BRIEF DESCRIPTION OF THE ILLUSTRATIONS OF THE DRAWINGS

In the following an embodiment of the invention is described by means ofthe Figures showing the following:

FIG. 1 a top view of the cartridge according to the invention,

FIG. 2 a perspective view of the cartridge,

FIG. 3 a perspective view of the cartridge, sectioned along a symmetryline,

FIG. 4 a sectional perspective view of the cartridge supplementing theview of FIG. 4,

FIG. 5 a further perspective and sectional view of the cartridge,

FIG. 6 a bottom surface of a cover of the cartridge,

FIG. 7 a perspective view of an accommodating box,

FIGS. 8 a to 8 c schematic sectional views of the cartridge, from whichthe cell isolation can be seen, and

FIG. 9 shows the flow of the blood product through the filter.

WAY(S) TO CARRY OUT THE INVENTION

An embodiment of the invention is described by means of FIGS. 1 to 9.

A cartridge 1 essentially consists of a partition wall 3 and a cover 9.The partition wall defines a blood bag section 5 and a product bagsection 7. When the cartridge 1 is inserted into a system box 89 of therotor of a centrifuge, the blood bag section 5 is located radiallyinside of the partition wall 3, whereas the product bag section 7 islocated radially outside of the partition wall 3. An accommodating box89 according to the invention is designated as system box 89.

A cover 9 is provided above the blood bag section 5. It has anessentially rectangular shape and, in its closed state, one of itslongitudinal walls is in contact with the partition wall 3. In onecorner point, the cover is pivotally mounted in the partition wall,whereas, in a second corner point, it is engaged with the partition wall3 by means of a bolt 10. For opening the cover, pressure is applied ontothe bolt 10 and then the cover is pivoted to the side. Thereby, theblood bag section 5 is freely accessible and can be filled with a bloodbag 35.

By means of the simple pivoting mechanism a tube 36 and a blood bag 35can quite easily be held in a desired position when the cover 9 isclosed, and can be fixed in this predetermined position by closing thecover 9.

After the cover 9 has been closed it is possible to insert the tube 36into the recesses 15, 19 which are formed in the top surface of thecover 9. A first photo sensor 25 is provided in the recess 15.

A tube clamp 34 in its closed state, which is delivered together withthe blood bag and which is disposed on the tube, for example oneproduced by “Halkey Roberts”, is accommodated in a recess 17 also formedin the top surface of the cover 9.

The end of the tube 36 which is the far end with respect to the bloodbag 35 leads to the product bag section 7 where it is connected to aleukocyte filter 31 which is held in a fixture 29. The tube 36 isinserted into the leukocyte filter 31 radially from the outside and frombelow. The insertion of the filter 31 and the tube 36 is enabled bymeans of a slot 73 in an outside wall 71 of the fixture 29. Through theslot 73, the tube 36 connected to the filter 31 can be displaced fromtop to bottom when the filter is inserted into the fixture, such thatthe tube leads to the filter radially from the outside and from below.

Behind the filter 31, the tube 36 leads, via second recesses 75, 79, 81,83 which are provided in the cover 9 and which are essentiallypositioned in a mirror-image manner relative to the recesses 15, 17, 19to the product bag 33, which is located radially outside of the fixture29.

A second tube clamp 34 is provided in the recess 81. A second photosensor 85 is located in the recess 79.

Inside the cover 9, two rods 21, 23 as operating device for operatingthe clamps 34 are respectively led through the cover such that one oftheir ends protrudes slightly from a side surface 8 of the cover 9,which is located opposite the partition wall 3, and the other end islocated in the area of the recess 17 accommodating the clamp 34. Byapplying a pressure onto one of the ends protruding from the sidesurface 8, the customary clamp 34 can thus be opened and closed.According to the embodiment, the tube clamps 34 can be operatedindividually as well as pneumatically.

After the cartridge 1 has been loaded, the cartridge 1 can be insertedinto the system box 89 of the rotor of a centrifuge. When this is done,the side surface 8 of the cover 9 which is located opposite thepartition wall 3 rests on a support 57 of the system box 89, which isprovided in the area of a hub of the centrifuge. Moreover, at thesupport 57, there is a rod-shaped locking element 55 which has aprojection 56 at its radial outside. By means of inserting the cartridge1, the side surface 8 of the cover 9 slides over the projection 56 andmoves the locking element 55 radially inward until the side surface 8 ispositioned below the projection 56 and the locking element 55 springsback to its original position and thus prevents an upward displacementof the cartridge 1. Now the cartridge 1 is firmly positioned between theoutside wall of the system box 89 and the support.

According to the embodiment, the rotor of the centrifuge is designed forsix system boxes 89 having one cartridge 1 each. After all cartridges 1have been inserted, the centrifuge is started. By means of thecentrifugal force, the desired separation of the blood components iseffected. Since the “buffy coat” diluted by an additive solution is inthe blood bag 35, its lighter components will remain radially inside,whereas heavier components, i.e. the red blood cells collect outside.

In order to transport the desired blood component—according to theembodiment, these are the platelets—in high quality, i.e. without theadmixture of other blood cells, from the blood bag, the separation ofthe components will be followed by a slight pressure being applied ontothe blood bag by means of a known pressure pad 61, so that, after theclamps 34 have been opened, the solution rich in platelets begins torise into the tube 36 leading upwards and radially inwards. The solutionrich in platelets is led through the tube 36 into the leukocyte filter31 into which it enters radially from the outside and from below.

In the leukocyte filter 31, the undesired leukocytes, i.e. the whiteblood cells, are removed. Due to the arrangement according to theinvention of the tube 36 having the filter 31, the filtration iseffected against the centrifugal force. Thus, heavier blood components,such as unintentionally fed red blood cells, are trapped in a front-endchamber of the filter, positioned radially outwards.

After having passed the leukocyte filter 31, the solution rich inplatelets continues flowing through the tube 36 into a product bag 33,in which it is collected. Preferably, the product bag 33 is alreadyformed as final storage bag for the product. The entire process isschematically illustrated in FIGS. 8 a to 8 c.

In order to remove any air that might be present in the filter, the flowspeed is kept low for a certain volume quantity at the beginning of theproduct transfer, and thus it is enabled that the filter fills reliablyand completely with the blood product. After the transfer of thispredetermined volume quantity, the transport speed for a specific secondvolume quantity is increased by means of an appropriate control of thepressure pad. While this second volume is transported, there is hardlyany risk that red blood cells contaminate the blood product (here: thethrombocyte concentrate). In case this nevertheless happens, this smallnumber of red blood cells is collected in the lower and outer areas ofthe filter, due to the feeding of the tube 36 from radially outside andbelow into the filter and due to the effect of the centrifugal force.

After the second volume has been transferred, the first photo sensor isactivated and the flow speed of the blood product in the tube 36 isreduced.

When the first photo sensor 25 detects a predetermined proportion of redblood cells in the thrombocyte-rich solution, it outputs a signal bymeans of which the flow speed is again reduced. Furthermore, the secondphoto sensor 85 arranged behind the filter 31 is activated.

During this phase, also a rather large number of red blood cells canenter into the filter 31 and even pass through it, until the secondphoto sensor 85 detects a predetermined proportion of red blood cells inthe blood product and outputs a signal for terminating the cellisolation process. By means of this signal, the tube clamps 34 areclosed by means of activating the rod 23, so that the red blood cells inthe filter are reliably separated from the thrombocyte concentrate inthe product bag. The operation of the rod is effected by means of anactuating mechanism provided in the system box 89.

As an alternative to the termination by means of the second photo sensor85, the cell isolation process can also be terminated after a certainperiod of time has elapsed after the second photo sensor 85 has beenactivated.

In the embodiment, altogether six cartridges are provided in thecentrifuge. The above described control of the cell isolation process ina cartridge 1 by means of a pressure pad 61, the opening and closing ofthe tube clamps 34 and the process control by means of the two photosensors 25, 85 enables a continued cell isolation in the cartridges ofthe other system boxes 89, since the described process control operatesindividually for each combination of cartridge and system box.

For the transmission of the control and other electrical signals, anelectric contact pad in the form of individual contact points 59 isprovided at the support 57 of the system box 89. At the bottom surfaceof the cover 9, contact surfaces 27 assigned to the contact points 59are provided and get into contact with the contact points 59 when thecartridge 1 is inserted into the system box. For this purpose, thecontact points 59 are spring-mounted.

For the purpose of an easier handling, on the one hand, and in caseblood components should escape due to a damage of the bags 33, 35, thetube 36 or the filter 31, the cartridge 1 is inserted into a collectingtank 87 from a radially inward direction. In case of a damage, theescaping blood component is largely collected in the collecting tank sothat there would only be little contamination of the system box 89 or ofthe rotor itself. In such a case, the system box 89 can be easilydismounted from the rotor.

After the cell isolation has been terminated, each of the cartridges 1is removed by applying a slight pressure onto the locking element 55 inorder to move this radially to the inside.

Simultaneously, the cartridges 1 are seized at the finger holes 88 ofthe collecting tank 87, lifted upwards out of the system box 89 of thecentrifuge, and are immediately replaced by new freshly loadedcartridges 1. During the subsequent cell isolation, the blood bags 35and the product bags 33 can be removed from the exchanged cartridges 1and these can be reloaded.

The invention relates to a cartridge (1) for accommodating blood bags(35), which is provided for the separation of blood components for theapplication in a centrifuge. The cartridge (1) has a partition wall (3)which separates a blood bag section (5) which is positioned radiallyinside from a product section (7) positioned radially outside, and acover (9) disposed in a mounting position above the blood bag section(5). The cover (9) is connected to the partition wall (3) pivotally in afirst point (11) and detachably in a second point (13), so that theblood bag section (5) is freely accessible by means of laterallypivoting the cover (9) out of the way. The cartridge is applicable inthe rotor of a centrifuge.

The invention claimed is:
 1. A cartridge for accommodating a set of bagsfluidly connected by at least one tube, said cartridge to be used in acentrifuge for separation of blood components, the cartridge beingadapted to be removably mounted in a rotor of the centrifuge, saidcartridge comprising a blood bag section; a product section; a partitionwall which separates the blood bag section of the removable cartridgefrom the product section, and a cover coupled to the removable cartridgeabove the blood bag section, wherein the cover is connected to theremovable cartridge pivotally at a first point on said cartridge anddetachably at a second point on said cartridge, so that the blood bagsection is freely accessible by means of laterally pivoting the coverfrom the blood bag section and wherein said cover has a top surface anda bottom surface as defined when the cover is detached from the secondpoint and pivoted to an open position and further comprising at leastone recess for holding said at least one tube, said recess being formedin said top surface of the cover.
 2. A cartridge according to claim 1,wherein an operating device is provided in the cover for operating atube clamp disposed on said tube.
 3. A cartridge according to claim 2,wherein the operating device protrudes from the cover at a side surfacelocated opposite the partition wall when the cover is closed.
 4. Acartridge according to claim 1, wherein a photo sensor is provided inthe at least one recess.
 5. A cartridge according to claim 1, wherein anelectric connection means for electrical connection with the centrifugeis provided at a bottom surface of the cover.
 6. A cartridge accordingto claim 1, wherein a fixture for receiving a filter fluidly connectedby a tube to at least one of said bags of said set bags is providedadjacent said partition wall and outside of the blood bag section.
 7. Acartridge according to claim 6, wherein the fixture comprises an outerwall positioned substantially parallel to the partition wall and havinga guiding means for guiding the tube connected to said filter.
 8. Acartridge according to claim 7, wherein the guiding means is a slot inthe outer wall of the fixture.
 9. A cartridge according to claim 6,wherein, a recess is provided at a top surface of the partition wall forguiding the tube connected to the filter from the fixture to at leastone second recess in the top surface of the cover, and the second recessbeing configured to receive the tube and a tube clamp.
 10. A cartridgeaccording to claim 9, wherein the second recess is a mirror-image ofsaid first recess with respect to a center line of said cover.
 11. Acartridge according to claim 10, wherein the partition wall furthercomprises a passage at an upper edge of the partition wall for feedingthe tube from the blood bag section to the product section.
 12. Acartridge according to claim 2, wherein a first photo sensor is provideddisposed in the at least one recess and a second photo sensor isdisposed in an at least one second recess, and a second operating deviceis provided for operating a second tube clamp.
 13. A cartridge accordingto claim 1, in further comprising a collecting tank positioned outsideof and embracing the product section and parts of the blood bag section.14. A cartridge according to claim 13, wherein the collecting tank isprovided with a handling means for handling the cartridge.
 15. Thecartridge as in claim 1, wherein said cartridge is adapted to fit intoone of a plurality of accommodating boxes surrounding a hub of acentrifuge rotor revolving about said hub, such that the cover extendsaway from said blood bag section towards said hub; and is adapted toengage a locking element connected to the hub of the rotor, the lockingelement being configured to lock the cartridge to the rotor.
 16. Acartridge according to claim 15, wherein the bottom surface of the coveris adapted to contact a support at the hub of the cartridge and whereinthe bottom surface of the cover is provided with a contact pad forestablishing an electrically conductive connection between the rotor andthe cartridge.
 17. A cartridge according to claim 15, wherein a sidesurface of the cover is adapted to engage the locking element, the sidesurface being located opposite the partition wall.
 18. A cartridgeaccording to claim 15, wherein said product section is open oppositesaid partition wall such that a pressing element can be displacedoutward from the hub of the centrifuge for applying pressure onto ablood bag in the cartridge, the pressing element being located proximateto the hub.
 19. The removable cartridge of claim 1 wherein the coverfurther comprises a recess configured to receive a customary clamp. 20.The removable cartridge of claim 19, further comprising: at least onerod led through said cover, said rod having a first end protruding froma side surface of said cover and a second end protruding into saidrecess for said clamp, whereby said rod is adapted to open and closesaid clamp in said recess.